Journal of Clinical and Translational Science
◐ Cambridge University Press (CUP)
Preprints posted in the last 30 days, ranked by how well they match Journal of Clinical and Translational Science's content profile, based on 11 papers previously published here. The average preprint has a 0.02% match score for this journal, so anything above that is already an above-average fit.
Thompson, S.; Ong, L.; Marquez, B.; Molina, A. J. A.; Trinidad, D. R.; Edland, S. D.
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Improving diversity in U.S. Alzheimers disease (AD) research is a pressing need. By 2050, Hispanic and Latino Americans will comprise 30% of the population. Hispanics are 1.5 times more likely and Blacks are twice as likely to develop AD compared to Whites, yet both remain vastly underrepresented in clinical trials research. Aging and AD research mentorship of underrepresented STEM undergraduates is designed to promote entry into related professions by students committed to decreasing disparities in AD research participation and clinical care. The NIA-funded MADURA program recruited 93 students from backgrounds historically underrepresented in STEM majors and/or from NIH-defined disadvantaged backgrounds. Trainees were placed in aging/AD research labs and received weekly training and mentorship from faculty research PIs and other types of supervisors (postdoctoral researchers, graduate students, research assistant staff...) Our study examined student ratings of the program and mentor behaviors, using a program-specific survey and the Mentoring Competency Assessment-21 (MCA-21). Trainees were highly satisfied with both mentoring relationships and the overall program. Student rated MCA-21 competency areas were quite high for both P.I.s and other types of research mentors. However, there were striking differences in associations between competencies and relationship and program satisfaction, by mentor type. For PI mentors, no MCA-21 competencies were associated with relationship satisfaction, but five of six competencies were associated with relationship satisfaction for other mentor types. Similarly, no PI mentor competencies were significantly correlated with overall placement satisfaction, but all six competencies were correlated with overall placement satisfaction for other mentor types. The authors discuss the likelihood of differing student expectations of faculty PI versus other types of research mentors, recommendations for assessing role-specific student expectations (including functions primarily possible only for senior faculty PIs), and utilizing nearer-peer plus PI faculty mentors to comprehensively address the gamut of mentee needs.
Henson, J. C.; Spears, G. L.; Daughdrill, B. K.; Hagood, J. N.; Vallurupalli, S.
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Background: Cardiac rehabilitation (CR) is a cost-effective, evidence-based intervention that improves outcomes for patients with heart failure (HF), yet access remains inequitable, particularly among Medicaid enrollees. This study evaluates the state-by-state variability in Medicaid coverage for CR services and examines the implications for health equity in vulnerable populations. Methods: We conducted a cross-sectional policy analysis of all 50 U.S. states to assess Medicaid coverage for outpatient CR services billed under CPT codes 93797 (without ECG monitoring) and 93798 (with ECG monitoring). Publicly available Medicaid documents were reviewed and supplemented with direct communication with state Medicaid agencies. States were categorized into full, partial/inconclusive, or no coverage. Geographic trends were visualized through heat maps and contextualized using state-level Medicaid enrollment data. Results: Marked disparities in CR coverage were identified. Only 41 states reimbursed for CPT 93797, and 43 for CPT 93798. Eight states lacked coverage for either code, predominantly in the South and Mountain West, including Arkansas, Georgia, Louisiana, Mississippi, Nevada, and Utah. States with the highest Medicaid enrollment (e.g., Louisiana, Arkansas) often provided no CR coverage, compounding access barriers for high-risk, low-income populations. Conclusions: The absence of standardized Medicaid coverage for CR contributes to systemic inequities in cardiovascular care, disproportionately impacting disadvantaged communities. Aligning Medicaid policies to ensure universal CR access--particularly through tele-rehabilitation and value-based care models--could reduce hospitalizations, improve survival, and promote health equity across the U.S.
Bianchina, N.; Fischer, C.; Rai, K.; Clawson, J.; McBeth, L.; Gottenborg, E.; Keniston, A.; Burden, M.
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BackgroundHigh workload among healthcare workers has increasingly been correlated with poor patient outcomes, inefficient operational and financial outcomes, and burnout. Despite growing literature exploring causes of attending physician workload, there is limited understanding of trainee-specific measures. ObjectiveWe aimed to characterize elements contributing to trainee workload and perceived challenges and satisfiers to the trainee workday as a foundation for better understanding and measuring trainee work experience. MethodsInternal Medicine and Medicine-Pediatrics residents at an academic medical center were invited to participate in focus groups discussing contributors to inpatient workload and work experience between March and April 2024. A qualitative content analysis identified key metrics of trainee workload and work experience, which were then consolidated into overarching domains. A structured, multi-round rating process ranked the perceived relevance of each metric. ResultsTwenty residents participated across six focus groups. Analysis of focus groups yielded 297 workload metrics across 28 unique domains. Seventeen domains had metrics identified as highly relevant (median 6-7; IQR < 1) including autonomy, communication, disruptions, task switching, documentation, emotional burden, patient factors, professional fulfillment, rounding, teaming, and work-life balance. ConclusionsResident physicians highlighted complex interactions between clinical factors, work design, and psychosocial dynamics that contribute to their sense of workload. This creates opportunities to develop unique measures of workload to understand the trainee experience better. Further studies are needed to capture the generalizability of these findings and the relationship between these workload domains and patient, organizational, and trainee outcomes with the aim of implementing evidence-based work design.
Phillips, V.; Woodwal, P.
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BackgroundArtificial intelligence and machine learning (AI/ML) are among the fastest-growing domains in NIH research funding, but whether children have shared equitably in this expansion is unknown. We characterized pediatric representation in NIH AI/ML funding from fiscal years (FY) 2020 to 2024. MethodsNIH grant data were obtained from Research Portfolio Online Reporting Tools Expenditures and Results bulk files for FY2020 to FY2024. AI/ML grants were identified using the NIH Research, Condition, and Disease Categorization "Machine Learning and Artificial Intelligence" category, and pediatric grants using the "Pediatric" category. Subprojects were excluded. Grants were deduplicated within each fiscal year by core project number for trend analyses and across all years retaining the most recent fiscal year for cross-sectional totals. Disease areas were identified by keyword searches of titles and abstracts. ResultsAcross FY2020 to FY2024, 5,624 unique NIH AI/ML grants totaling $3,371 million were identified. Of these, 836 grants (14.9%) were classified as pediatric, representing $401 million (11.9%) of total NIH AI/ML funding. Although this share was consistent with the historically reported overall NIH pediatric funding baseline of approximately 10% to 12%, it remained substantially below the US pediatric population share of approximately 22%. The pediatric share of NIH AI/ML funding declined from 12.3% in FY2020 to 10.8% in FY2024, despite growth in absolute pediatric funding. Indexed to FY2020, pediatric AI/ML funding grew approximately 2.6-fold compared with 3.0-fold growth in the total portfolio. Across disease areas, unadjusted adult/general-to-pediatric funding ratios ranged from 2.0-fold in mental health to 9.8-fold in cancer. ConclusionsPediatric representation in NIH AI/ML funding remained low and declined over time as the overall portfolio expanded. These findings suggest that growth in NIH AI/ML investment has not been matched by proportional gains for pediatric research.
King, B.; Beech, B.; Jones, O.; Castillo, E.; Attri, S.; Buck, D. S.
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Background Persons experiencing homelessness (PEH) have a 2-3-fold greater risk for cardiovascular disease (CVD) mortality compared with domiciled counterparts. Evidence has repeatedly shown elevated chronic disease burden, reduced access to many types of care, and lower utilization of medication to control CVD risk factors in clinical settings dedicated to providing health care to PEH. There are federally funded health clinics targeting barriers to access for patient populations experiencing homelessness in place. These clinics are frequently overwhelmed and limited by their scope to primary care despite well documented burdens of co- and tri-morbid conditions. There is scarce evidence on differences between access, quality, and experiences of care delivered relative to other safety-net models. Method The 2022 Health Center Patient Survey (HCPS) was collected on behalf of the Health Resources and Services Administration (HRSA). The HCPS is a nationally representative, three-staged, sample-based survey collected via 1:1 interview with clinic patients. The survey assessed sociodemographics, health conditions and behaviors, access to and utilization of care, and patients? experiences with comprehensive services they received at HRSA-funded Federally Qualified Health Centers (FQHCs), including community health centers (CHC), healthcare for the homeless (HCH) clinics, and public housing primary care (PHPC) clinics. One hundred and three unique awardees and 318 health center sites were recruited, and 4,414 patient interviews were completed. Investigators analyzed patient characteristics and multiple survey items related to AHA?s Essential 8 metrics for differences between HCH and CHC patient responses. Results HCH clinics had fewer elderly patients (~7%) than CHCs (~17%). Reported 7-day physical activity measures, average sleep below 7 hours per day, and Lifetime smoking (>100 cigarettes; OR=4.2, p<0.001) were all greatest among HCH patients. Fewer HCH patients reported ever having or recent lipid tests (both p<0.001). HCH patients were more likely to report hypertension (p=0.003) but less likely to report receiving nutrition advice (all p<0.05). HCH patients were less likely to be taking medication even if it was prescribed (p<0.001). Adjustments for differences in age or CVD history were able to explain some observed differences but increased the magnitude of other disparities. Conclusions CVD burden differs across the various HRSA funding mechanisms for clinics, as do demographics and multiple metrics of health behaviors and biomarkers of cardiovascular health. Greater disease burden in HCH patients is likely compounded by increased risk factors and underperformance in providing health education interventions.
Streicher, N. S.
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Background and ObjectivesPatient portals have become essential infrastructure for healthcare delivery following the 21st Century Cures Act, yet adoption remains inequitable. Understanding demographic and geographic determinants of portal activation is critical for addressing digital health disparities, particularly among neurology patients who face unique access barriers. We examined the demographic, geographic, and neighborhood-level factors associated with patient portal activation among neurology patients at multiple geographic scales in the Washington, DC metropolitan area. MethodsWe conducted a retrospective cohort study of 72,417 adult neurology patients seen at two academic medical centers sharing an electronic health record in Washington, DC (February 2021-February 2026). We examined portal activation using multivariable logistic regression and geographic analysis at four nested scales: the metropolitan catchment area, DCs eight wards, individual census tracts (via geocoded patient addresses), and individual DC residents. ResultsPortal activation was 64.7% overall. Activation varied by race/ethnicity (Non-Hispanic White 76.1%, Non-Hispanic Black 57.0%, Non-Hispanic Asian 57.6%, Hispanic 55.0%) and geography (DC Ward 2: 82.0% vs. Ward 7: 48.0%). Ward-level educational attainment (r = 0.948), broadband access (r = 0.889), and income (r = 0.811) were strongly correlated with activation. Within individual wards, Non-Hispanic White patients activated at 84-91% while Non-Hispanic Black patients activated at 48-64%, demonstrating that neighborhood resources alone do not explain disparities. DiscussionPatient portal activation is shaped by demographic, socioeconomic, and geographic factors operating at multiple levels. Persistent within-ward racial disparities indicate that geographically targeted interventions must be paired with culturally tailored approaches to achieve digital health equity.
Shireman, J.; Mukherjee, N.; Brackman, K.; Kurtz, N.; Patniak, A.; McCarthy, L.; Gonugunta, N.; Ammanuel, S.; Dey, M.
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Objectives: Academic medical institutions are the gatekeepers of the physician workforce and shape the future of medicine by regulating medical school admissions as well as residency training. Although broadly the field of medicine is seeing more representation from traditionally underrepresented groups, the critical decision-making platform of academic medicine continues to be uncharacteristically homogeneous, represented mainly by white males. This is even more pronounced in surgical subspecialties, such as academic neurosurgery. This study aims to quantify this phenomenon, uncover its driving factors, and define opportunities for improvement. Methods: Using a mixed research methodology, academic neurosurgical faculty in the U.S were identified, and their demographic data was collected. An internet search using Google Scholar and Scopus was conducted to determine scholarly activity using number of publications and h-index. Results: We found a significant increase in female faculty in academic neurosurgery within the last decade. Comparing the faculty rank amongst male and female faculty, we found that the majority of female faculty are at the assistant professor level (n=36/79; 45.6%) while male faculty are more at the full professor rank (n=265/582; 45.5%). A similar trend was seen for under-represented minority neurosurgery faculty. Strong scholarly activity corelated with a departmental chair position for male faculty, however, this trend was not true for female faculty. There was a significant difference in the number of publications and h-index in female vs male faculty, but only when including male faculty outliers at the full professor level. Conclusion: Slowly but steadily, academic neurosurgery is making progress towards a more diverse and representative workforce in the U.S that better reflects the patient population. Facilitating timely progression of females and URM neurosurgeons into senior professorship and academic leadership roles will further advance this essential progress.
Hawke, L. D.; Hou, J.; Upham, K.; van Kesteren, M. R.; Munro, C.; Hauer, S.; Sendanyoye, C.; Halsall, T.; Quilty, L.; Hamilton, C.; Barbic, S. P.; Wang, W.
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Background. People with lived/living experience of health conditions, as well as caregivers, are increasingly engaged in research. This study aimed to develop and pilot test a new tool measuring the impact of lived/living experience engagement on the research. The measure is called the Measure of Engagement Tool for Research and lived Experience (METRE). Method. We conducted a qualitative descriptive study among 28 people with lived/living experience and caregivers and 12 academic researchers to understand the impacts of engagement. Using the findings, we drafted the METRE. We pilot tested the METRE among 13 people with lived/living experience and caregivers and 10 academic researchers. Insights were used to refine the scale. Results. Qualitatively, participants identified multiple domains of impact of engagement on research, which guided scale development. Pilot testing of the draft METRE revealed it being straightforward to complete, providing a thorough evaluation of the impact of engagement. However, some areas of improvement were recommended. The draft items showed acceptable preliminary performance. Conclusions. An assessment tool is now available to assess the impact of lived/living experience engagement on the research. Additional research is required to evaluate its psychometric properties. Tools to evaluate the impact of engagement on research will help advance the science of engagement and support engaged research teams in their work.
Rai, K.; Bianchina, N.; Fischer, C.; Clawson, J.; McBeth, L.; Gottenborg, E.; Keniston, A.; Burden, M.
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Purpose: High clinical workload is associated with worse patient and hospital outcomes and is a well-established driver of clinician burnout. Trainees may be particularly exposed, shouldering both clinical and educational responsibilities. Evidence-based work design offers a data-driven approach to healthcare work but relies on robust workload measurements. Trainee workload remains poorly characterized, as commonly used metrics (e.g., duty hours, patient census) overlook cognitive and contextual dimensions. This pilot evaluated the feasibility of combining survey-based and electronic health record (EHR) data to characterize internal medicine (IM) trainee workload. Methods: A pilot study was conducted including IM and Medicine-Pediatrics residents (postgraduate years 1-4) between March 31 and June 22, 2025. Participants completed daily surveys during a seven-day inpatient schedule assessing workload and work experience domains, including environment, professional fulfillment, psychological safety, autonomy, and rounding experience, using validated instruments where available. Concurrently, EHR data captured chart review, documentation, orders, and secure messaging activity. Associations between survey and EHR data were assessed. Results: Among 37 eligible residents, 28 (76%) participated in the pilot capturing 166 shifts. Trainees spent 4.4 +/- 1.6 (mean +/- SD) minutes completing daily surveys and 8.6 +/- 2.3 minutes completing the final survey. Trainees reported working 11.6 +/- 1.0 hours/day and a median census of 9.0 (IQR 6.0-11.0). NASA-TLX score was 50.8 +/- 12.6. Positive shift ratings were associated with lower NASA-TLX scores and perceived rounding length. First-to-last EHR login duration was 15 +/- 2 hours/day, and EHR data showed 204 +/- 46 active minutes/day. Login duration correlated with self-reported hours (r=0.43, p<0.0001), and notes signed correlated with self-reported team (r=0.19, p=0.013) and personal census (r=0.34, p<0.0001). Conclusions: Integrating survey-based and EHR-derived workload measures provides multidimensional insight into trainee work. This novel approach supports scalable measurement and evidence-based work design interventions to improve trainee well-being, education, and clinical efficiency.
xia, y.; Sun, L.; Zhao, Y.
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Background: China has implemented policies to strengthen its pharmacist workforce since the 2009 healthcare reform, yet a comprehensive evaluation of their long-term systemic effects is lacking. Objective: To systematically analyze the evolution of Chinas pharmacist workforce in healthcare institutions from 2007 to 2023 across four dimensions: quantity, quality, structure, and distribution, providing an empirical foundation for policy optimization. Methods: A retrospective analysis was conducted using longitudinal data from the China Health Statistics Yearbooks. Trends were delineated via descriptive statistics. Equity and spatial evolution were assessed using the Gini coefficient, Theil index decomposition, and spatial autocorrelation analyses (Global Morans I and hotspot analysis). Results: From 2007 to 2023, the total number of pharmacists increased from 357,700 to 569,500 (average annual growth: 2.2%). This growth lagged behind physicians (4.6%) and nurses (7.4%), causing the pharmacist-to-physician ratio to decline from 1:5.15 to 1:8.39. The workforce showed trends of feminization (female proportion rose from 59.7% to 70.8%) and aging. While quality improved, 51.1% still held an associate degree or below, and only 6.6% held senior titles. Equity analysis revealed the provincial Gini coefficient improved from 0.145 to 0.093. Theil index decomposition confirmed intra-provincial disparities as the primary inequality driver. Spatial analysis showed a non-significant global Morans I by 2023 (0.154, P*>0.05), down from 0.254 (P<0.01) in 2007. Hotspot analysis confirmed this transition, revealing a contraction of high-confidence clusters and a trend toward balanced distribution. Conclusions: China has made measurable progress in expanding pharmacist workforce size and improving inter-provincial equity since 2007. However, persistent structural challenges remain: relative workforce contraction compared to other health professions, an aging demographic, a shortage of senior talent, and significant intra-provincial inequity. Future policies must prioritize optimizing workforce structure and enhancing clinical service capabilities to catalyze a shift toward patient-centered pharmaceutical care.
Ng, J. Y.; Tan, J.; Syed, N.; Adapa, K.; Gupta, P. K.; Li, S.; Mehta, D.; Ring, M.; Shridhar, M.; Souza, J. P.; Yoshino, T.; Lee, M. S.; Cramer, H.
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Background: Generative artificial intelligence (GenAI) chatbots have shown utility in assisting with various research tasks. Traditional, complementary, and integrative medicine (TCIM) is a patient-centric approach that emphasizes holistic well-being. The integration of TCIM and GenAI presents numerous key opportunities. However, TCIM researchers' attitudes toward GenAI tools remain less understood. This large-scale, international cross-sectional survey aimed to elucidate the attitudes and perceptions of TCIM researchers regarding the use of GenAI chatbots in the scientific process. Methods: A search strategy in Ovid MEDLINE identified corresponding authors who were TCIM researchers. Eligible authors were invited to complete an anonymous online survey administered via SurveyMonkey. The survey included questions on socio-demographic characteristics, familiarity with GenAI chatbots, and perceived benefits and challenges of using GenAI chatbots. Results were analysed using descriptive statistics and thematic content analysis. Results: The survey received 716 responses. Most respondents reported familiarity with GenAI chatbots (58.08%) and viewed them as very important to the future of scientific research (54.37%). The most acknowledged benefits included workload reduction (74.07%) and increased efficiency in data analysis/experimentation (71.14%). The most frequently reported challenges involved bias, errors, and limitations. More than half of the respondents (57.02%) expressed a need for training to use GenAI chatbots in the scientific process, alongside an interest in receiving training (72.07%). However, 43.67% indicated that their institutions did not offer these programs. Discussion: By developing a deeper understanding of TCIM researchers' perspectives, future AI applications in this field can be more informed, and guide future policies and collaboration among researchers.
Blankson, P.-K.; Hussien, S.; Idris, F.; Trevillion, G.; Aslam, A.; Afani, A.; Dunlap, P.; Chepkorir, J.; Melgarejo, P.; Idris, M.
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BackgroundRecruitment remains a major barrier to timely clinical trial completion. Trialshub is an LLM-powered, chat-based platform intended to help users identify relevant trials and connect with coordinators to streamline recruitment workflows. ObjectiveTo evaluate the perceived usability and operational value of Trialshub, and identify implementation considerations for real-world deployment. MethodsA usability test was conducted at Morehouse School of Medicine for the Trialshub application. Purposively selected participants included clinical research coordinators and individuals with and without clinical trial search experience. Participants completed a pre-test survey assessing demographics, digital health information behaviors, and familiarity with AI tools, followed by a moderated usability session using a Trialshub prototype. Users completed scenario-based tasks (locating a breast cancer trial, reviewing results, and initiating coordinator contact) using a think-aloud protocol. Task ratings, screen recordings, and transcribed feedback were analyzed descriptively and thematically, and reported. ResultsParticipants reported high comfort with using digital tools and moderate-to-high familiarity with AI. Trialshubs chat-first design, guided prompts, and checklist-style eligibility display were perceived as intuitive and reduced cognitive load. Fast access to trials and the coordinator-contact workflow were viewed positively. Key usability issues included uncertainty at step transitions, insufficient cues for selecting results and next actions, and inconsistent system reliability (loading delays, errors, and broken trial detail pages). Participants also noted redundant questioning due to limited conversational memory, requested improved filtering/sorting, and clearer calls-to-action. All participants indicated that Trialshub has strong potential to meaningfully improve clinical trial processes. ConclusionsTrialshub shows promise for improving trial discovery and recruitment workflows, with identified design implications for real-world deployment.
Thomas, C.; Kim, J. Y.; Hasan, A.; Kpodzro, S.; Cortes, J.; Day, B.; Jensen, S.; LHuillier, S.; Oden, M. O.; Zumbado Segura, S.; Maurer, E. W.; Tucker, S.; Robinson, S.; Garcia, B.; Muramalla, E.; Lu, S.; Chawla, N.; Patel, M.; Balu, S.; Sendak, M.
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Safety net healthcare delivery organizations (SNOs) serve vulnerable populations but face persistent challenges in adopting new technologies, including AI. While systematic barriers to technology adoption in SNOs are well documented, little is known about how AI is implemented in these settings. This study explored real-world AI adoption in SNOs, focusing on identifying barriers encountered across the AI lifecycle and strategies used to overcome them. Five SNOs in the U.S. participated in a 12-month technical assistance program, the Practice Network, to implement AI tools of their choosing. Observed barriers and mitigation strategies were documented throughout program activities and, at the conclusion of the program, reviewed and refined with participants using a participatory research approach to ensure findings reflected lived experiences and organizational contexts. Key barriers emerged during the Integration and Lifecycle Management phases and included gaps in AI performance evaluation and impact assessments, communication with patients about AI use, foundational AI education, financial resources for purchasing and maintaining AI tools, and AI governance structures. Effective strategies for addressing these barriers were primarily supported through centralized expertise, structured guidance, and peer learning. These findings provide granular, actionable insights for SNO leaders, offering guidance for anticipating barriers and proactively planning mitigation strategies. By including SNO perspectives, the study also contributes to the broader health AI ecosystem and underscores the importance of participatory, collaborative approaches to support safe, effective, and ethical AI adoption in resource-constrained settings. Author SummarySafety net organizations (SNOs) are healthcare systems that primarily serve low-income and underinsured patients. While interest in artificial intelligence (AI) in healthcare has grown rapidly, little is known about how these organizations experience AI adoption in practice. In this study, we partnered with five SNOs over a 12-month program to document the challenges they encountered when implementing AI tools and the strategies they used to address them. We worked closely with SNO staff throughout the process to ensure our findings reflected their lived experiences with AI implementation. We found that the most common challenges arose when organizations tried to integrate AI into daily operations and monitor and maintain those tools over time. Specific barriers included difficulty evaluating whether AI was performing as expected, limited guidance on communicating with patients about AI use, a lack of resources for staff training, limited financial resources, and the absence of formal governance structures. Successful strategies for overcoming these challenges drew on shared knowledge and structured support provided by the program, as well as learning from peer organizations. These findings offer practical guidance for SNO leaders planning or managing AI adoption, and contribute to a broader conversation about what is required to implement AI safely and effectively in healthcare settings that serve the most medically and socially vulnerable patients.
Tai, K. H.; Varvara, G.; Escoffier, E.; Mansmann, U.; DeVito, N. J.; Vieira Armond, A. C.; Naudet, F.
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Objective To map the presence, public availability, and content of clinical trial data sharing policies (DSP), data management and sharing plans (DMSP), and data use agreements (DUA) among the most prolific public and private clinical trial sponsors operating in the European Union, and to identify key areas of convergence, divergence, and constraint in the context of General Data Protection Regulation (GDPR). Eligibility criteria We included organisation-level documents describing approaches to clinical trial data sharing or data management from the top 20 public and top 20 private sponsors ranked by the number of trials registered in the EU Clinical Trials Information System (CTIS). Eligible materials comprised publicly available or sponsor-shared policies, guidelines, statements, templates, and agreements relevant to clinical trial data sharing or management. Sources of evidence Evidence was identified through systematic searches of sponsors' public websites, structured Google searches, and major data management plan platforms (DMPTool, DMPonline, DMP Assistant), complemented by direct contact with sponsors to verify findings and request missing documentation. All sources were archived and catalogued. Charting methods Two reviewers independently extracted data using a structured form, capturing the existence, accessibility, and content of data sharing policies, data management and sharing plans, and data use agreements. Quantitative data were summarised descriptively, and a non-interpretive descriptive content analysis was conducted to characterise recurring policy elements and areas of heterogeneity. Results Among 40 sponsors, private sponsors were substantially more likely than public sponsors to make trial-specific data sharing policies and data use agreements publicly accessible, often via established data sharing platforms. Public sponsors more frequently referenced data management and sharing plans, but these were heterogeneous in scope and often embedded within broader institutional governance documents rather than tailored to clinical trials. Across sectors, GDPR compliance, data protection, and legal safeguards were emphasised, while operational aspects such as dataset readiness, review criteria, and downstream responsibilities varied widely. Overall response rate to sponsor verification was 37.5%. Conclusion Clinical trial data sharing governance in the EU shows a marked sectoral imbalance among the top sponsors. Private sponsors tend to provide more detailed and operationally explicit documentation, whereas public sponsors often articulate high-level commitments without trial-specific guidance. Greater clarity and standardisation, particularly among public sponsors, could improve transparency and facilitate responsible data reuse, while remaining compatible with GDPR requirements.
Claus, L.; McNamara, M.; Oser, C.; Fogle, C.; Canine, B.
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Cardiovascular disease (CVD) remains the leading cause of mortality in the United States, despite being largely preventable through effective management of risk factors. This study evaluates the impact of Phase II cardiac rehabilitation (CR) on functional capacity and quality of life, using data from the Montana Outcomes Project Cardiac Rehabilitation Registry. Functional capacity improvements were assessed via the six-minute walk test (6MWT) and Dartmouth COOP questionnaire, with statistical analyses exploring the influence of CR session attendance, demographic factors, and referring diagnoses. Results demonstrated significant gains in 6MWT, with a mean improvement of 330.73 feet (p < .0001), and quality of life scores across all subgroups. A dose-response relationship was observed, indicating greater improvements with increased CR sessions (p < .0001), though diminishing returns were observed beyond 24-35 visits. Demographic factors and complex conditions influenced outcomes, underscoring the need for tailored strategies to enhance CR access and effectiveness. These findings highlight the critical role of CR in improving patient outcomes and emphasize the importance of addressing barriers to participation in underserved populations.
Winn, C.; Groene, L.; Colby, S.; Ademu, L.; Olfert, M. D.; Byrd-Bredbenner, C.; Mathews, A.; Stabile Morrell, J.; Brenes, P.; Brown, O.; Barr-Porter, M.; Greene, G.; Dhillon, J.
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Background: College-attending young adults frequently experience declines in diet quality, physical activity, and psychological well-being during the transition to independent living, contributing to weight gain during the first year of college. Although multicomponent lifestyle interventions have been developed to address these behaviors, the responsiveness to such programs could differ across demographic factors associated with health behaviors, such as sex, race, and ethnicity. Hence, this secondary analysis of large-scale college health trials evaluated whether the effectiveness of such interventions differed by these demographic factors. Methods: Data were combined from two multi-site randomized controlled trials: Young Adults Eating and Active for Health (YEAH) trial and the Get FRUVED trial. Both interventions used theory-based approaches to promote healthy weight management through improvements in diet quality, physical activity, and stress management. Baseline-adjusted linear regression models evaluated the effects of group (intervention, control) and its interactions with sex, race (White, Black, Other), or Hispanic ethnicity. Models were adjusted for baseline outcome values, baseline BMI, study (YEAH vs. FRUVED), and state of data collection. Results: Intervention participants reported higher fruit and vegetable intake, lower processed meat intake, and longer sleep duration compared with controls. However, there was significant heterogeneity in these dietary outcomes by ethnicity, race, and sex. Non-Hispanic participants in the intervention group had higher fruit and vegetable intake compared to controls (p < 0.05). And, within the intervention group, Hispanic females had lower bacon/sausage intake than Hispanic males and non-Hispanic females (p < 0.05). With respect to race, Black participants reported higher total processed meat intake than White and Other race participants (p <0.05). These demographic factors did not moderate the intervention's impact on physical activity, sleep duration, and perceived stress. Overall, the intervention appeared to be the least effective for Hispanic males who exhibited higher body weight and waist circumference compared with Hispanic females and non-Hispanic males (p < 0.05). Conclusions: Multicomponent lifestyle interventions can improve selected dietary outcomes among college students, but effectiveness may differ across demographic subgroups. Culturally and sex-tailored strategies that consider the intersecting influences of sex, race, and ethnicity may enhance intervention effectiveness during the transition to college.
Mahdikhani, S.; Cleary, F.; Cummins, S.
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Objectives: Endometriosis affects approximately 10% of reproductive age women worldwide, yet care pathways remain fragmented and treatments have limitations. This study aimed to identify and categorize key stakeholders in endometriosis care in Ireland, assess their influence and interest in the digital health initiative, and identify drivers and barriers affecting uptake of innovative approaches to care. Methods: A virtual stakeholder mapping workshop was conducted with participants from healthcare, policy, education, technology, academia, and patient communities. Using a structured MS Teams Whiteboard, participants generated a stakeholder list, positioned stakeholders on an Influence-Interest Matrix, and provided qualitative insights on factors enabling or constraining engagement with digital health innovation. Results: Stakeholders were distributed across all four quadrants of the matrix. High-interest/high-influence stakeholders included the HSE, specialist centres, general practitioners, and the Endometriosis Association of Ireland. High-interest/low-influence groups comprised patients, families, and online communities, while policymakers, hospital managers, and the education sector were identified as high-influence but low-interest actors. Key drivers included strong patient advocacy, institutional support such as engagement from the HSE, and growing awareness of digital health tools. Major barriers encompassed prolonged diagnostic delays, resource constraints, gaps in clinical knowledge, technology anxiety, and challenges sustaining engagement. Conclusions: Stakeholder mapping provided an evidence-informed foundation for the VendoR project, revealing engagement gaps and leverage points critical for improving endometriosis care innovation. The findings highlight the need for intentional, well-resourced strategies that elevate patient voices, address systemic barriers, and ensure balanced representation, supporting the co-design, co-creation, and co-production of digital health interventions for sustainable, patient-centred care.
Henderson, D.; Lignier, B.; Moxham, B.; Plaisant, O.; OSCEs study group, U. P. C.; Buffel du Vaure, C.; Faye, A.; Bouzid, D.; Lemogne, C.; Guedon, A.
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ABSTRACT Objective Structured Clinical Examinations (OSCEs) are widely used to assess medical students clinical skills, including non-technical abilities such as communication and empathy. However, the potential influence of individual psychological traits, such as personality dimensions, empathy, and stress-related mindset on OSCE performance remains understudied. This study investigated associations between personality traits, empathy levels, stress mindsets, and performance in OSCEs among medical students. An online questionnaire (including the Big Five Personality Traits Inventory 2, the Jefferson Scale of Physician Empathy (Medical Student version), the Growth Mindset Scale, the Stress Mindset Measure) was provided to all fifth-year medical students enrolled at the Universite Paris Cite for six weeks before undertaking graduation summative OSCEs. Their scores were correlated with OSCE performance using Spearmans correlation and linear regression analyses. A total of 99 questionnaires were included and analysed. None of the psychometric tests we assessed showed a significant correlation with OSCE scores. The strongest predictors of success in OSCEs were higher scores in written examinations, previous OSCE performance, and being female. In non-interactive OSCE stations, conscientiousness was the only significant predictor, with a positive association (p=0.001). Neuroticism was positively associated with performance improvement between OSCE sessions (p=0.042). Personality traits, self-reported empathy, and stress-related mindsets do not predict success in OSCEs as isolated traits. Further research is needed to determine whether it holds true for all kinds of OSCEs. Multidimensional psychometric assessment may be relevant when investigating performance outcomes in OSCEs.
Kemal, R. A.; Dhani, R.; Simanjuntak, A. M.; Rafles, A. I.; Triani, H. X.; Rahmi, T. M.; Akbar, V. A.; Firdaus, F.; Pratama, B. F.; Zulharman, Z.
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Background: Increasing relevance of genetics and molecular biology in medicine necessitates greater genetic literacy among healthcare workers. To assess the literacy level, a validated genetic literacy questionnaire is needed. Therefore, a standardised Indonesian-language genetic literacy questionnaire is essential. Aims: We aimed to translate and validate three genetic literacy questionnaires (PUGGS, iGLAS, and UNC-GKS) for use among Indonesian medical students. We then evaluated genetic literacy levels using one of the validated questionnaires. Methods: The PUGGS, iGLAS, and UNC-GKS questionnaires were translated into Indonesian and then reviewed by an expert panel for translational accuracy and conceptual appropriateness. Back-translation was performed to confirm validity. Initial Indonesian versions of the questionnaires underwent cognitive pre-testing with 12 undergraduate medical students. After refinements, the questionnaires were validated among 34 first- to third-year medical students. The Indonesian version of UNC-GKS questionnaire was then used to assess genetic literacy of 486 medical students comprising 228 preclinical medical students, 187 clerkships, and 71 residents. Results: The Indonesian versions of PUGGS (Cronbach's = 0.819) and UNC-GKS ( = 0.809) demonstrated good reliability, while iGLAS showed poor reliability ( = 0.315). Among the 486 students tested, 56% demonstrated moderate overall genetic literacy, and only 15.2% demonstrated good overall literacy. Basic genetic concepts were relatively well-understood with 54.3% having good literacy. On the contrary, gene variant's effects on health were poorly understood with only 9.7% having good literacy. Inheritance concepts were moderately understood with 24.9% having good literacy. Conclusion: The Indonesian translations of PUGGS and UNC-GKS are reliable tools for assessing genetic literacy among medical students. Using UNC-GKS, we observed predominantly moderate genetic literacy levels. Curriculum improvement to better integrate genetics education is essential to support its clinical applications.
Werner, R. J.; Karim, S. T.; Cunningham, M. A.; Moultrie, L. H.; Goodwine, M. L.; Ueberroth, L. A.; Wolf, B. J.; Allen, C. G.; Kamen, D. L.; Ramos, P. S.
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Background The Precision rEsearCh pArticipatioN (PECAN) study aims to explore factors that influence perceptions of precision health research participation, focusing on diverse communities in South Carolina. The objective is to identify both positive and negative factors affecting participation, enabling the development of strategies to enhance understanding and reduce barriers, particularly within a population facing significant health disparities. Methods To ensure the effectiveness of the survey instrument for the PECAN study, researchers conducted a cognitive study through guided group discussions with community members. These discussions were designed to pinpoint survey questions that participants found difficult to understand, hard to answer, or unclear. The insights gained from this cognitive evaluation were used to refine and improve the survey, ensuring it is clear, uniform, and effective for gathering meaningful data. Results The cognitive interview study identified several survey items that participants found challenging or ambiguous, particularly due to complex wording, culturally irrelevant content, and questions requiring extensive recall. Participants emphasized the need for clearer language, reassurance about anonymity, and the use of biological terms, as well as greater cultural representation. Based on this feedback, researchers revised the survey to simplify language, provide contextual disclaimers about specimen collection, depersonalize genetic testing questions, and restructure redundant items. Conclusions The cognitive interview study was instrumental in enhancing the PECAN survey's clarity and effectiveness. By addressing participants' feedback, the researchers were able to create a more accessible survey instrument. These improvements are expected to facilitate better data collection, ultimately contributing to a deeper understanding of factors influencing precision health research participation among diverse populations. This methodology highlights the importance of participant feedback in developing research tools that are both inclusive and effective.